Crusader for the Rights of Research Volunteers

SSKRP ATTORNEYS IN THE NEWS

Chronicle of Higher Education Jan 2002

By GOLDIE BLUMENSTYK Pennsauken, N.J.

Alan C. Milstein mixes novel legal theories with a strategy of suing everyone in sight.

Four and counting.

Since settling a lawsuit in 2000 against the University of Pennsylvania over the death of Jesse Gelsinger in a gene-therapy experiment, Alan C. Milstein has been on a bit of tear, suing universities and other research institutions for how they treat patients in clinical trials.

In addition to a second lawsuit against Penn, filed in December on behalf of a woman who was in the same gene-therapy trial as Mr. Gelsinger, Mr. Milstein has (with other lawyers) sued the University of Oklahoma over patients' treatment in a clinical trial for a melanoma vaccine and the Fred Hutchinson Cancer Research Center, in Seattle, over an experimental drug used in bone-marrow transplants.

Also in 2001, he became co-counsel for plaintiffs in a much-watched lawsuit against the University of California at Los Angeles that may finally come to trial next month, a decade after it was filed. The case could be the first courtroom test of whether members of an institutional review board can be held liable for damages for failing to oversee patients' safety in a clinical trial. An IRB is a panel of medical experts and others who are responsible for approving all experiments involving people.

In racking up the cases, Mr. Milstein, 48, makes no bones about his motives. He's a plaintiffs' lawyer looking to collect damages for his clients and share in the take. One of six principles in a 30-lawyer firm here in a suburb of Philadelphia, Mr. Milstein takes those informed-consent cases on contingency. (The percentages vary by case, he says. Typically, lawyers get one-third.)

The soft-spoken, self-declared "'60s liberal" says his second motive is no less important: Use the law to reform a system that often neglects the rights of people who agree to participate in medical experiments.

"The quantity of research going on is part of the problem," Mr. Milstein says. And "the quantity of the research is a function of the money that's involved."

Universities, he says, are among the worst offenders. For one, more and more of them seem entranced by the potential for riches in, say, discovering a new drug or medical cure. For another, he says, the pressure on academics to advance their careers, and especially to win tenure, sometimes blinds researchers to the risks the projects can impose on patients.

Trends in the medical industry only add to the problem. For the past few years, academic medical centers have been pushing hard to win back clinical-trial business that they had been losing to private testing companies and medical practices. And with patents for so many lucrative drugs expiring, pharmaceutical companies have become more aggressive about testing new products to replace them. At some institutions, Mr. Milstein notes, thousands of experiments take place under the supervision of just two or three IRB's.

"Fortunately, most researchers are conducting themselves in a professional manner," he says. But there are some who don't, he adds, and the oversight system doesn't necessarily catch them.

Mr. Milstein is not the only one speaking out about improving such oversight and ensuring that patients truly are informed about risks before they consent to take part in medical experiments. The deaths of Mr. Gelsinger and of Ellen Roche, a healthy 24-year-old who died in an asthma study at the Johns Hopkins University in July, brought a glare of media attention to the issues. And the problems have been pounded repeatedly in hearings and reports by Congress, federal agencies, and various medical groups. One of the latest airings came last May from the presidentially appointed National Bioethics Advisory Commission. It concluded that the existing oversight system was not protecting medical-research volunteers and that the nation's 3,500 to 5,000 IRB's were too overwhelmed by the volume of work to do their jobs effectively.

But while the commission, and others, recommended legislative changes and more money to improve IRB training, Mr. Milstein maintains that his "more radical" approach is better, because it exposes problems.

He argues, for example, that a "tremendous opportunity was lost" when Ms. Roche's family decided not to sue Johns Hopkins. Represented by another lawyer, the family settled in October for undisclosed terms. "There were a lot of things that needed to come out that didn't come out," says Mr. Milstein, adding that he respects the family's choice.

Also, he says, lawsuits can more directly change universities' behavior: "If you're worried about getting sued, you're careful about doing things."

Craig A. Schoenfeld, the Roches' lawyer, says the family didn't sue because it and Johns Hopkins "didn't want to see this get dragged through the mud for years." Also, he notes, Maryland caps damage awards in ways that Pennsylvania does not. Still, Mr. Schoenfeld says, he has "every confidence that we were totally informed as to the circumstances surrounding Ellen's death at Hopkins."

Mr. Milstein's lawsuits include claims against universities, doctors, IRB members, companies developing experimental drugs, and even staff bioethicists, for allegedly failing to fully inform the people they recruit for medical experiments about all the potential risks of participating. The lawsuits seek to hold such defendants accountable for not properly overseeing patients' safety. In some cases -- notably those against Oklahoma, Penn, and the Hutchinson center -- the suits also seek damages from defendants for allegedly not telling participants about the financial interests in the research of the institutions, doctors, and companies. At the Hutchinson center, for example, the doctors and an affiliated foundation owned stock in the company whose product was being tested.

Treatment of that sort, Mr. Milstein alleges, deprives his clients of their right to be treated with "essential human dignity" while serving as subjects of medical research.

"It's a human-rights issue," he says.

Sometimes, he asserts, it is a constitutional issue as well.

In the lawsuits he filed recently against state universities and officials, Mr. Milstein seeks to establish legal precedents by making the defendants liable on constitutional grounds, for violating the 14th Amendment. The amendment says that no state can "deprive any person of life, liberty, or property, without due process of law."

Getting that precedent established, Mr. Milstein says, "will have a tremendous influence on the nature of research in this country."

Of course, it's easier to file a lawsuit than to win one. And Mr. Milstein's track record in the field is mostly unproven. Penn, which settled the Gelsinger case for an amount never revealed but rumored to be several million dollars, has stated it will vigorously oppose the latest lawsuit. The Hutchinson center, Oklahoma, and UCLA also show no signs of folding.

Nonetheless, Mr. Milstein's tactics are getting university officials' attention -- and drawing a range of responses.

Critics, including some who regard him as just a cut above an ambulance chaser, say his legal theories are iffy at best and his legal rhetoric overly dramatic and even offensive. Most of his lawsuits, they note, don't uncover problems but merely capitalize on failings previously identified by government regulators or the news media, as was the case with a Seattle Times series about the Hutchinson center.

They also question the efficacy of his tactics, arguing that fears of being sued could scare people away from serving on IRB's and could discourage vital but risky research.

Admirers, meanwhile, say Mr. Milstein has helped elevate the issues before the public by filing lawsuit after lawsuit, by posting a rich resource of bioethics information on his law firm's Web site, and by speaking at public meetings on medical subjects' safety.

More than a few have praised Mr. Milstein for his courage, too.

"He's taking embryonic legal theories, and he's out there slugging everybody in sight," says Stephen Hanlon, a lawyer in Florida who was one of the first to win a dignity claim in a lawsuit over medical research. Mr. Hanlon is the lawyer who sued the University of South Florida on behalf of thousands of poor women who weren't fully informed about the experimental drugs and amniocentesis procedures administered to them during their pregnancies. He won a settlement of $3.8-million in 2000, but it took 10 years.

"I'm sure people are going to say he's into it for the money. If he is, he's a fool," says Mr. Hanlon, who applauds Mr. Milstein for his readiness to take on universities, doctors, pharmaceutical companies, and many others who regard him as an impediment to the progress of science. "The whole biomedical industry has an interest contrary to his."

For that reason, Mr. Hanlon says, Mr. Milstein's lawsuits are important: "He's got the chance to do something great here."

That chance at greatness came quite by accident.

Mr. Milstein's introduction to the informed-consent issue came from the Gelsinger lawsuit, a case that landed in his lap only because Paul Gelsinger, Jesse's father, has a brother who was a friend of one of the Firm's other partners.

The 25-year-old firm, Sherman, Silverstein, Kohl, Rose & Podolsky, didn't even handle medical malpractice. But the more Mr. Milstein learned about the Gelsinger case, the rules for medical experimentation, and the philosophy of informed consent, the more interested in the issue he became.

The circumstances of the case "inspired him," Mr. Gelsinger says.

Mr. Milstein began by teaching himself the history of bioethics. Jewish but not religious himself, he says he became fascinated by the topic, and was intrigued that so much of the bioethics canon had roots in Jewish law.

After years of working in computer and insurance law, he found himself confronting some of the headiest issues he could imagine.

"The whole future of medical science depends on human research, and society in general has an interest in advancing science and medicine," he explains. Yet "that may be contrary to an individual's interest."

While far from a bioethics expert -- friends call him a "fast learner" -- Mr. Milstein has gained insights into the problems from his self-education program.

He even has his own agenda for reform. Among his suggestions: Trivial experiments should be barred, as should experiments in which the researchers or the institutions have a financial interest in the outcome. "You can't manage conflict of interest," he argues, citing federal rules and standards that often allow such research to proceed as long as the financial interests are disclosed.

He also would like to see the greater use of "subject advocates," who could help ensure that potential volunteers in medical experiments are fully informed before they consent to participate.

An occasional college instructor (he's taught computer law at Temple University) and former part-time art critic for the now-defunct Philadelphia Bulletin, Mr. Milstein enjoys his new role.

"People have come to realize that I have something to say," he says, reflecting one December afternoon at his firm's headquarters. He has a corner office, but the aura is anything but "high-powered lawyer." His windows overlook the parking lot of the suburban office park where the law firm is housed. There are no trophy photographs; most of the pictures behind and beside his desk show him with his wife and three children. One is of him standing with Arlo Guthrie. Off to his right is a poster of the familiar black-and-white of John and Bobby Kennedy huddling in conversation. It's "a great photograph," Mr. Milstein says, but it also reminds him of the idealism about public service and human rights that the Kennedys, especially Bobby, inspired.

Admirers see a public purpose in Mr. Milstein's work, though some add that they worry he enjoys his fame a bit too much. "He likes getting a name out there for himself," Mr. Gelsinger says. "I cautioned him on that."

Mr. Milstein acknowledges that he savors the limelight.

"I get kicks out of it," he says. That's not only because of the ego boost it provides, and not only because he thinks he can do some good for society while also doing well for himself. It goes back, he says, to some of his early idealistic notions about the power of the legal system and the role of a litigator in that system. "Being a lawyer is very important to me."

In the courtroom, however, idealism goes only so far.

Lawyers for several defendants in Mr. Milstein's lawsuits say his legal theories are shaky, especially his attempts to raise the "dignity" claim to the level of a constitutional right.

"I've been over my Constitution up, down, and sideways, and I don't see that in there," says Joseph M. Hassett, a lawyer in Washington who represents the Hutchinson cancer center. The center maintains that it "acted at all times in the interests of its patients," he adds. Lawyers for the Oklahoma defendants have also challenged the constitutional claim.

In trying to establish the dignity right, Mr. Milstein's pleadings cite a number of internationally recognized codes of conduct for protecting patients in medical experiments. One of them is the Nuremberg Code, drafted in response to the heinous experiments that Nazi doctors performed on concentration-camp inmates.

Nina M. Gussack, a lawyer who represented Penn in the Gelsinger case and now in the second informed-consent suit, contends that such tactics go too far.

References to Nuremberg are "dramatic and inflammatory," she says. "It's offensive -- it's offensive to those who suffered from the true damages done by the Nazis."

Using such language, Ms. Gussack adds, "really does a disservice to a constructive dialogue." Even in a lawsuit, she says, you can question safeguards "without being extremist."

Mr. Milstein counters that criticism like that is offensive itself. The Nuremberg Code established minimum standards for patient consent, patient protection, and reducing risks, he notes. "The Nazi doctors fell far below the Nuremberg Code," but their actions prompted the consensus that medical volunteers deserve protection. "To say that the University of Pennsylvania violated the Nuremberg Code doesn't mean they're Nazis," he says.

Looking beyond the specifics of his legal arguments, some also question the value of the lawsuits altogether.

"Suing places into submission" can't work as a reform, just as suing doctors for malpractice does little to reduce errors in medical care, says Arthur Caplan, a bioethicist at Penn.

"The point of litigation is to get money for clients and get money for attorneys."

Mr. Caplan is not a disinterested party. He was one of the people Mr. Milstein sued in the Gelsinger suit, though he was later dropped from the case by mutual agreement. Mr. Caplan says he shares Mr. Milstein's belief that the system for protecting patients "is broken," but he disagrees over how to fix it.

The lawsuits, he says, could drive doctors and IRB members into trying to protect themselves rather than patients. That could cause researchers to avoid risky areas of research that would help sick people.

Mr. Caplan says he is also concerned that suing university bioethicists -- which Mr. Milstein did again in the Oklahoma case -- could make his colleagues censor themselves, to the detriment of researchers and patients.

"In the academic setting, it could intimidate people from speaking informally," Mr. Caplan says.

Other bioethicists say that such a fear may be overblown.

"If you're a professional, you need to be willing to stand by what you say," says Mary Faith Marshall, a bioethicist and professor of medicine at the University of Kansas Medical Center.

The same is true for IRB members. "They do need to be accountable," she says. "That certainly is the message Alan Milstein is sending."

Ms. Marshall, who also heads the National Human Research Protections Committee, a federal advisory board, says many IRB members lack proper training. "They're handed a notebook and told, 'Good luck.'"

Mr. Milstein's lawsuits "are a sign of a certain degree of failure on our part to protect human subjects," Ms. Marshall says. If medical centers would spend more time and money training IRB members, it would go a long way toward fixing some of the problems, she says. And "it's a lot cheaper to resource your IRB than to pay Alan Milstein."

Meanwhile, Mr. Milstein says he plans to keep the lawsuits coming: "I think there is a lot of money to be made here."

ALAN C. MILSTEIN'S LAWSUITS OVER CLINICAL TRIALS

Gelsinger v. University of Pennsylvania Filed: September 2000 Status: Settled in November 2000 for an undisclosed amount. Defendants: The university, three researchers involved in a gene-therapy clinical trial, the dean of the medical school at the time, and the university's bioethicist. (The dean and the bioethicist were dropped from the suit before it was settled.) The case: Paul Gelsinger alleged that his son Jesse, 18, died as a result of participating in a gene-therapy clinical trial, and that the defendants had not adequately informed either father or son about the medical risks of those experiments, or about the financial interests that one of the researchers and the university had in the tests.

Robertson v. J. Michael McGee Filed: January 2001 Status: Pending Defendants: Include Dr. McGee and other principal investigators at the University of Oklahoma Health Sciences Center at Tulsa, the 12 members of the institutional review board there, and a bioethicist who consulted with the board. The case: Dawanna Robertson and other participants in clinical trials for a melanoma vaccine allege, among other claims, that the defendants failed to provide volunteers with adequate information about the potential risks and violated other federal regulations governing such trials. The plaintiffs allege that such actions breached their rights to be treated with essential human dignity and that such a breach violates their "liberty" rights under the 14th Amendment to the Constitution.

Wright v. Fred Hutchinson Cancer Research Center Filed: March 2001 Status: Pending. In November 2001, a federal judge rejected arguments to have the case tried as a class action. Defendants: Include the Hutchinson center and three of its researchers, who are also faculty members at the University of Washington; a foundation related to the center; and Genetic Systems, a company whose drug was being tested in the study. The company had given stock and positions to the three researchers, and stock and cash to the foundation. The case: William Lee Wright and Peggy Drahein, spouses of cancer patients who died after participating in an early-1980s clinical trial, were the initial plaintiffs. The two patients died following a test of a drug designed to reduce graft-versus-host disease during bone-marrow transplants. The plaintiffs allege that their spouses were enrolled in the trial without adequate informed consent, and that the defendants' actions constituted fraud, violations of federal laws governing human-subject research, and a breach of the subjects' rights to be treated with dignity.

Aderman v. University of Pennsylvania Filed: December 2001 Status: Pending Defendants: The university, the university hospital, and three doctors involved in a gene-therapy clinical trial. The case: Dolores Aderman, who was a patient in the same clinical trial as Jesse Gelsinger, alleges that the defendants failed to disclose fully the potential medical risks of the treatments or the financial interests the university and one of its doctors had in the success of the study. She alleges that her right to be treated with "essential human dignity" was breached.

Aller v. University of California at Los Angeles Filed: March 1992 (Mr. Milstein was brought into the case as co-counsel in 2001). Status: Trial is tentatively scheduled to start on February 19. Defendants: Include the University of California, the doctors who ran the clinical trial, and members of the university's institutional review board. The case: In what is believed to be the first lawsuit involving claims against a university's institutional review board to go to trial, Gregory Aller and his parents allege that the university misled them about the risks of a study on withdrawing medication from people with schizophrenia. The case has been joined with another filed by the parents of Antonio Lamadrid, another participant in the trial, who committed suicide in 1991.